The U.S. Food and Drug Administration is proposing to limit the materials used in some medical products in order to keep them free of the agent thought to cause mad cow disease, also known as bovine spongiform encephalopathy or BSE.

This is the latest in a series of BSE safeguards that would bar material that has been found to harbor the highest concentrations of this fatal agent in infected cattle. These materials would be prohibited from use as ingredients in medical products or elements of product manufacturing.

The proposed rule would cover drugs (prescription, over-the-counter, and homeopathic), biologics (such as vaccines) and medical devices intended for use in humans as well as drugs intended for use in ruminant animals like cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.

"These measures build on a series of barriers FDA and the U.S. Department of Agriculture have erected to further protect humans from exposure to the fatal agent linked to BSE," said Andrew von Eschenbach, M.D., Commissioner Food and Drugs. "This proposed rule adds one more safeguard that will reduce the risk of transmission even further."

The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include:

the brain, skull, eyes and spinal cords from cattle 30 months and older; the tonsils and a portion of the small intestines from all cattle regardless of their age or health; any material from "downer" cattle--those that cannot walk; any material from cattle not inspected and passed for human consumption; fetal calf serum if appropriate procedures have not been followed to prevent its contamination with materials prohibited by this proposed rule; tallow that contains more than 0.15 percent insoluble impurities if the tallow is derived from materials prohibited by this proposed rule and; mechanically separated beef. To ensure that companies comply with these prohibitions, FDA proposes to require that records be kept to demonstrate that any cattle material used as an ingredient in these medical products or as part of their manufacturing process meet the rule’s requirements.

Since 1996, strong evidence has accumulated for a causal relationship between ongoing outbreaks of mad cow disease in Europe and a disease in humans called variant Creutzfeldt-Jakob (vCJD) disease. Both disorders, which are thought to be caused by an unconventional transmissible agent, are invariably fatal brain diseases with incubation periods typically measured in years. Transmission of the BSE agent to humans, leading to vCJD, is believed to occur via ingestion of cattle products contaminated with the BSE agent; however the specific products associated with this transmission are unknown.

About 200 cases of vCJD have been identified worldwide, including three cases in the U.S. However, there is no evidence that those three patients contracted the BSE agent in the U.S.

FDA and USDA’s efforts to help protect the public from vCJD have included several other significant steps such as the FDA’s 1997 ruminant feed regulation, which forbids the use of certain mammalian-origin proteins in ruminant feed. Also, a 2005 interim final rule bans the use of certain high-risk cattle material in food, dietary supplements and cosmetics.

[TSS]yes, thank you,U.S. cattle, what kind of guarantee can yougive for serum or tissue donor herds?

[no answer, you could hear in the back ground,mumbling and 'we can't. have him ask the questionagain.]

[host Richard]could you repeat the question?

[TSS]U.S. cattle, what kind of guarantee can yougive for serum or tissue donor herds?

[not sure whom ask this]what group are you with?

[TSS]CJD Watch, my Mom died from hvCJD and we aretracking CJD world-wide.

[not sure who is speaking]could you please disconnect Mr. Singeltary

[TSS]you are not going to answer my question?

[not sure whom speaking]NO

from this point, i was still connected, got to listenand tape the whole conference. at one point someonecame on, a woman, and ask again;

[unknown woman]what group are you with?

[TSS]CJD Watch and my Mom died from hvCJDwe are trying to tract down CJD and otherhuman TSE's world wide. i was invited tosit in on this from someone inside the USDA/APHISand that is why i am here. do you intend on banningme from this conference now?

at this point the conference was turned back up,and i got to finish listening. They never answeredor even addressed my one question, or even addressedthe issue. BUT, i will try and give you a run-downfor now, of the conference.

IF i were another Country, I would take heed to mynotes, BUT PLEASE do not depend on them. ask fortranscript from;

RBARNS@ORA.FDA.GOV301-827-6906

he would be glad to give you one ;-)

Rockville Maryland,Richard Barns Host

BSE issues in the U.S.,How they were labelling ruminant feed?Revising issues.

The conference opened up with the explaining ofthe U.K. BSE epidemic winding down with about 30cases a week.

although new cases in other countries were nowappearing.

Look at Germany whom said NO BSE and now have BSE.

BSE increasing across Europe.

Because of Temporary Ban on certain rendered product,heightened interest in U.S.

A recent statement in Washington Post, said theNew Administration (old GW) has a list of issues.BSE is one of the issues.

BSE Risk is still low, minimal in U.S. with a greaterinterest in MBM not to enter U.S.

HOWEVER, if BSE were to enter the U.S.it would be economically disastrousto the render, feed, cattle, industries,and for human health.

(human health-they just threw that in cause i was listening. I will nowjot down some figures inwhich they told you, 'no need to write them down'.just hope i have them correct. hmmm, maybe i hopei don't ???)

80% inspection of rendering

*Problem-Complete coverage of rendering HAS NOToccurred.

sizeable number of 1st time FAILED INITIAL INSPECTION,have not been reinspected (70% to 80%).

NON-FDA licensed millsThere is NO inventory on non licensed mills.approximately 6000 to 8000 Firms ???4,344 ever inspected."FDA does not have a lot of experience with"

40% do NOT have caution statement 'DO NOT FEED'.

74% Commingling compliance

"This industry needs a lot of work and only halfgotten to"

"700 Firms that were falitive, and need to bere-inspected, in addition to the 8,000 Firms."

Quote to do BSE inspection in 19 states by endof January or 30 days, and other states 60 days.to change feed status??? Contract check and askquestions and pass info.

At this time, we will take questions.

[I was about the third or fourth to ask question.then all B.S.eee broke loose, and i lost my trainof thought for a few minutes. picked back up here]

someone asking about nutritional supplements andsourcing, did not get name. something about inspectorsnot knowing of BSE risk??? the conference person assuring that SteveFollum? and the TSE advisory Committee werehandling that.

Some other Dr. Vet, whom were asking questionsthat did not know what to do???

[Dennis Wilson]California Food Agr.Imports, are they looking at imports?